Guangdong Wellknown Ceramics Co. Lt
⚠️ Moderate Risk
FEI: 3004058513 • Guangzhou, Guangdong • CHINA
FEI Number
3004058513
Location
Guangzhou, Guangdong
Country
CHINAAddress
Ceramics Building No 268 Huan, , Guangzhou, Guangdong, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is Guangdong Wellknown Ceramics Co. Lt's FDA import refusal history?
Guangdong Wellknown Ceramics Co. Lt (FEI: 3004058513) has 1 FDA import refusal record(s) in our database, spanning from 11/20/2007 to 11/20/2007.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Guangdong Wellknown Ceramics Co. Lt's FEI number is 3004058513.
What types of violations has Guangdong Wellknown Ceramics Co. Lt received?
Guangdong Wellknown Ceramics Co. Lt has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Guangdong Wellknown Ceramics Co. Lt come from?
All FDA import refusal data for Guangdong Wellknown Ceramics Co. Lt is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.